On June 24, 2017, Hogan Lovells attorneys Xin Tao (Washington DC Office) and Liang Xu (Beijing Office) spoke at the 15th Annual Conference of the Sino-American Pharmaceutical Professionals Association – Greater Philadelphia’s annual conference. Mr. Tao presented on the “Biosimilar Exclusivity and Interchangeability: A Legal Primer” for both innovators and biosimilar applicants. Mr. Liang presented
Tag Archives: biosimilar
Supreme Court Issues Landmark Biosimilar Ruling
On June 12, 2017, the Supreme Court issued a unanimous ruling in Sandoz Inc. v. Amgen Inc. The case interprets two provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and is expected to significantly impact the approval and patent litigation processes for biosimilar applications. First, the BPCIA requires a biosimilar applicant
AIFA publishes “Second Concept Paper” on biosimilars
On June 15, 2016, AIFA (the Italian Medicines Agency) published a “Second Concept Paper” on the use of biosimilars within the National Health System (NHS). The document is intended to start a discussion that should eventually lead to an amended or new version of the agency’s Position Paper of 28 March 2013 on the same
Netherlands MEB revises position on biosimilars and interchangeability
The Dutch Medicines Evaluation Board (MEB) published a new position on biosimilars, in which it accepts substitution or interchangeability of biosimilars under certain conditions. The MEB’s revised position on biosimilars was published on 31 March 2015 and replaces its previous position of 2010. The 2010 position provided that patients should be kept at the same
SCOTUS review of the Patient Protection and Affordable Care Act and “the biosimilar thing”
While a Supreme Court ruling on the constitutionality of the healthcare reform law is not expected until June, sponsors and regulators continue to lay the groundwork for biosimilars in the U.S. An unintended consequence of embedding the Biologics Price Competition and Innovation Act within PPACA without a severability clause leaves the biosimilars law vulnerable to
Awaiting FDA Guidance on Interchangeability for Biosimilars
The three draft Guidances recently released by the U.S. Food and Drug Administration on implementation of the Biologics Price Competition and Innovation Act of 2009 focus on how to demonstrate biosimilarity but don’t say much about demonstrating interchangeability. FDA has asked for stakeholder input on biosimilar interchangeability at the agency’s upcoming one-day public hearing on